Penalties for inadequate FDA GMP (Good Manufacturing Practices) System

G

gupho

#1
Hi,

Can anyone help me out with some information regarding penalties for failing to have an FDA GMP system (or failing to have an adequate one?) This is for a Class 1 Medical Device.

We are a startup company with a more or less finished product and a limited (i.e. nonexistant) budget, and are trying to get to a small-scale launch as soon as possible. We note that the FDA requires us to register our company and list our product within 30 days of "commercializing", which we take to mean our first sale. After that, my understanding is that we could be audited at any time.

We are experienced engineers and we do take quality and safety seriously as a matter of personal ethics. We have some systems in place to that end, but not a formal GMP quality system as defined by the FDA.

Some people within the organization are pushing to do the limited product release either without a GMP system, or with something minimal that we would throw together in a day or two. The idea is that we would then use the 30 days between launch and registration to implement and refine a system.

So here are my questions:

* Assuming that our product is not actually hurting people or otherwise unsafe, what is the worst possible penalty we can expect if we fail a GMP audit?
* If we are audited shortly after product release, how far back will documents in the GMP system need to go? Is there a chance that we could pass with documents starting just prior to the first sale, or do they need to go back to much earlier in the product development?
* Given that we are a small company, with a simple, low-risk product, how long would it take us to set up a proper system if we put a couple of smart, motivated engineers on the task full-time? (I realize it varies, but is there any way to estimate, short of hiring a consultant who we cannot currently afford to pay?)
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
* Assuming that our product is not actually hurting people or otherwise unsafe, what is the worst possible penalty we can expect if we fail a GMP audit?
I thought about this one a bit.

There are a lot of folks here who work for companies that incur substantial costs to comply. Is it fair for you to compete with them without that cost burden? Does it negatively affect the great majority of companies that are compliant when FDA has to allocate its limited resources to the QSIT system to find and stop companies like yours, instead of using those resources to (for instance) speed up the premarket clearance process?

As a matter of personal ethics, I'm not willing to provide advice on intentionally not complying with the law.
 

somashekar

Staff member
Super Moderator
#3
Hi,

Can anyone help me out with some information regarding penalties for failing to have an FDA GMP system (or failing to have an adequate one?) This is for a Class 1 Medical Device.

We are a startup company with a more or less finished product and a limited (i.e. nonexistant) budget, and are trying to get to a small-scale launch as soon as possible. We note that the FDA requires us to register our company and list our product within 30 days of "commercializing", which we take to mean our first sale. After that, my understanding is that we could be audited at any time.

We are experienced engineers and we do take quality and safety seriously as a matter of personal ethics. We have some systems in place to that end, but not a formal GMP quality system as defined by the FDA.

Some people within the organization are pushing to do the limited product release either without a GMP system, or with something minimal that we would throw together in a day or two. The idea is that we would then use the 30 days between launch and registration to implement and refine a system.

So here are my questions:

* Assuming that our product is not actually hurting people or otherwise unsafe, what is the worst possible penalty we can expect if we fail a GMP audit?
* If we are audited shortly after product release, how far back will documents in the GMP system need to go? Is there a chance that we could pass with documents starting just prior to the first sale, or do they need to go back to much earlier in the product development?
* Given that we are a small company, with a simple, low-risk product, how long would it take us to set up a proper system if we put a couple of smart, motivated engineers on the task full-time? (I realize it varies, but is there any way to estimate, short of hiring a consultant who we cannot currently afford to pay?)
Dear gupho ~~~
Welcome to the Cove.
It is really not possible to provide prescriptive answers to your 3 questions. However reading your good intent from your opening post (We are experienced engineers and we do take quality and safety seriously as a matter of personal ethics. We have some systems in place to that end, but not a formal GMP quality system as defined by the FDA.) and taking the clue from the post # 2 above, it makes good sense to approach your local FDA office on the GMP and premarket clearance process.
When you have systems in place, GMP will not a far thing with you as you have said this (put a couple of smart, motivated engineers on the task full-time?)
Please do come back on specific GMP and FDA related questions for some experienced visitors here to respond to you.
Good luck ~~~
 
G

gupho

#4
I get where you guys are coming from. I guess I should have given more context. There are multiple people involved in this decision. I'm the one trying to convince the others that we should comply. The resistance I am meeting falls into several categories:

* suggestions that the FDA must be inherently reasonable, and hence will not impose onerous requirements for what is obviously a safe product.
* philosophical discussions about the interplay of regulation and innovation, and their effect on the public good.
* suggestions that other companies which implement complex GMP systems have been scared into it by consultants who have an incentive to exaggerate the requirements.
* the (correct) observation that I am not very experienced in this area, and might be vastly overestimating what the FDA actually requires.

I could go on, but I think you get the idea. It's difficult to answer those sorts of questions when I am not an expert myself. My impression is that just reading the regulations is not a substitute for experience. Hence my presence here.

I focused on the penalties, not because I intend to break the law, but because if they are heavy, and I can show evidence that they are enforced, I can short-cut the other discussions and get on with implementation.

It would also help if I can show that implementation will be straightforward, relatively quick, and that we won't go through that effort only to be punished anyway because we didn't have the final system in place a year ago at the start of prototyping. I have no idea how to figure that out.

My impression is that there is some ambiguity in what is required, as a necessary consequence of having one system to cover all companies and products, and that most companies try to implement the simplest system that satisifies both the law and their own judgement of what is necessary. Is that correct?
 

somashekar

Staff member
Super Moderator
#5
I focused on the penalties, not because I intend to break the law, but because if they are heavy, and I can show evidence that they are enforced, I can short-cut the other discussions and get on with implementation.
Implementing = Establish + Implement + maintain
If you have some shortcoming you will get some 483's and opportunity to take time and suggest suitable corrective action to which the FDA agree (does not write back to you any disagreement) and you implement the same.
Failure at this level may lead to warning letter and could have business effects.
 
M

MIREGMGR

#6
It's unfortunate that your company set out to market a medical device either without recognizing that a medical device company is subject to different legal requirements than a company that makes other kinds of products, or with that recognition but a determination to not comply with those legal requirements.

As to what happens if/when you're caught:

1. A 483. This is the citation at time of inspection citing what was found to be wrong. If you don't have systems in place already, you are unlikely to be able to clear a 483 to FDA's satisfaction no matter what you try to do, to avoid the next step.

2. A Warning Letter. Many distributor organizations follow the issuance of Warning Letters and will shift their purchases to another supplier. Usually, governmental purchases will cease and associated imports may be held until the Warning Letter is cleared, which can take up to a year.

3. Usually, a required Recall. For a product that is not fixable in the field, usually this will involve recovery of product from the field, with replacement or buyback. Your company handles shipping and handling costs. Until your objectively evidenced recovery percentage is high enough, the FDA won't close out the Recall status.

(The following three are quoted from the usual Warning Letter language, and usually aren't applied when the FDA determines that the noncompliance was due to ignorance or incompetence and not deliberate.)

4. Seizure (of inventory and/or product in the field.)

5. Injunction (against further product-marketing business activities until FDA says OK. In one instance involving a GE division, this took 2+ years.)

(Sometimes to avoid legal costs and delays, the company agrees with FDA on a consent agreement in place of this step, in which the company agrees to cease activities until an FDA-acceptable consultant signs off to FDA that the company is in full compliance. My understanding is that was the approach in the Triad situation.)

6. Civil money penalties (against the company and/or its officers.)

(The following is statistically unlikely except in cases involving egregious intentional non-compliance.)

7. Criminal prosecution of company officers and owners.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
This is a bit "off topic", but because of the potential legal repercussions I want to remind folks that postings in this thread are the *opinions* of each poster and in no way are intended as legal advice to/for the original poster.
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
M Exemptions, Responsibilities, and Penalties (in Australia) Other Medical Device Regulations World-Wide 3
I Contractor Management-Are Penalties considered Corrective Action? Quality Manager and Management Related Issues 10
G PPAP and IMDS Penalties and Registrars RoHS, REACH, ELV, IMDS and Restricted Substances 16
J Suggestions on Inadequate Resources in a Small Machine Shop Nonconformance and Corrective Action 2
S Could I issue major finding for Inadequate Procedures Supplier Quality Assurance and other Supplier Issues 17
A MSA with Inadequate Part Variability Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Nadcap finding Inadequate Procedure and Inadequate Root Cause Analysis Nonconformance and Corrective Action 4
C Digital Timer Inadequate for Process? General Measurement Device and Calibration Topics 6
Q Process Maps identified as inadequate during registrar's Document audit Process Maps, Process Mapping and Turtle Diagrams 20
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 1
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 8
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
O Hospital-Developed, In-House Device - FDA Clearance? Other US Medical Device Regulations 19
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020) Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
Similar threads


















































Top Bottom